United StatesThe iLet Bionic Pancreas, REF BB1001 (software versions 1.4.2 and 1.4.3) distributed by Beta Bionics in the U.S. (TX, PA, AL, MI, OH, FL, TN, GA) is affected. It was recalled because an issue with the Dexcom G7 CGM can delay sensor readings and trigger a switch to non‑CGM dosing, resulting in only basal and requested meal doses while correction doses and insulin reductions/suspensions for high or low glucose may not occur, potentially causing severe hyperglycemia (with or without DKA) or severe hypoglycemia.
What's being recalled
iLet Bionic Pancreas, REF: BB1001
Recalling firm: Beta Bionics, Inc., Irvine, CA, United States.
How to identify it
Software versions 1.4.3, and 1.4.2
The hazard
insulin pump software versions 1.4.2, and 1.4.3 issue with Dexcom Continuous Glucose Monitoring (CGM) G7 sensor may result in delayed CGM reading then switch to non-CGM dosing, leading to only basal/requested meal doses provided, no correction doses/insulin reductions/suspensions for high/low glucose unless blood glucose entered for sensor life or replacement. Potential health risks to users include severe hyperglycemia with and without DKA and severe hypoglycemia.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution in the states of TX, PA, AL, MI, OH, FL, TN, GA.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)